Kornimate/medical-research-clean huggingface dataset:
comparison of aerosol inhalation and intravenous glucocorticoid in the treatment of severe aecopd

Conditions: Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Summary: comparison of aerosol inhalation and intravenous glucocorticoid in the treatment of severe aecopd-------multicenter, prospective, randomized, controlled clinical study

this study aims to compare the efficacy and comprehensive benefits of aerosol inhalation and intravenous injection of glucocorticoids in severe aecopd patients.

Eligibility criteria:
inclusion criteria: (1) patients with aecopd requiring hospitalization or emergency treatment (copd acute attacks combined with respiratory failure were eligible). (2) 18 years of age ≤80 years of age (3) patients and their families are willing to participate in clinical research and sign informed consent. exclusion criteria: 1. combined with tuberculosis. 2. combined bronchiectasis. 3. complicated with definite infectious diseases. 4. pct≥0.5ng/ml or crp≥30mg/l. 5. serious injury combined with other organ functions 6. contraindications to other glucocorticoid use. 7. concomitant bronchial asthma or positive bronchodilation test

Keywords: severe aecopd aerosol inhalation and intravenous glucocorticoid
neoadjuvant chemotherapy in advanced epithelial ovarian cancer (eoc): a phase iii randomized study

Conditions: Ovarian Carcinoma

Summary: to determine the impact of neoadjuvant chemotherapy on surgical debulking rate, overall and disease-free survival and quality of life (qol) in patients with advanced eoc.


Eligibility criteria:
inclusion criteria: * age:20 to 65 years * epithelial ovarian carcinoma * stage iiic \& iv (pleural effusion only) * ecog ps 0-2 * cytology/biopsy positive patients * good compliance * previously untreated patients exclusion criteria: * any medical contraindication of surgery * psychiatric illness * cardiac, liver or renal dysfunction

Keywords: epithelial ovarian cancer neoadjuvant chemotherapy randomized study
relation between near point of convergence and postural stability in subjects with non specific cervical pain

Conditions: Neck Pain

Summary: a correlation study was conducted to correlate between the convergence insufficiency and postural stability at three different cervical positions in patients with non-specific cervical pain.

a correlational study was conducted on eighty (male and female) subjects aged between 30-40 years old, presented with chronic nscp persisted for six months or more, with neck disability index score (ndi) ≥10%, and can possess at least 45° of left and right cervical rotation participated in the study. convergence insufficiency was evaluated by the near point of conversion (npoc) rule and postural instability was examined by the biodex balance system. results: there was significant positive correlation between (npoc) and anteroposterior stability index (apsi) at the three cervical positions; neutral, 45° right torsion and 45° left torsion (p\>0.05).

Eligibility criteria:
inclusion criteria: * age from 30 to 40 years. * chronic cervical pain ( 6 to18 months ago). * neck disability index (ndi) score ≥10%), * move 45° of cervical rotation to both the left and right. exclusion criteria: -neuromuscular or musculoskeletal disorders.
effect of manual therapy on obese individuals with low back pain

Conditions: Low Back Pain, Mechanical; Obesity

Summary: this study will investigate the effectiveness of mulligan mobilisation techniques sustained natural apophyseal glides (snags) and natural apophyseal glides (nags) on pain, disability, and range of motion (rom) in obese individuals with mechanical low back pain (lbp).

one of the most important methods in the treatment of lbp in recent years is manual therapy; manipulation, mobilisation and soft tissue techniques. with the manual techniques applied to the spine, the position and placement of the anatomical structures are changed and the tight and tense tissues are loosened. it has been observed that mulligan techniques can correct the faults that cause pain in the spine and that the structures that cause pain return to their normal functions when released. in the literature, it has recently been observed that the number of studies examining manual therapy and mulligan concept methods has increased. studies examining the effect of snag method on the lumbar region (12) and the effect of mobilisation and taping on chronic low back pain were found. however, no study was found in which snag and nags applications were applied on obese patients diagnosed with mechanical low back pain. therefore, in this study, snag and nags in obese patients with lbp to investigate the effectiveness of the practices

Eligibility criteria:
inclusion criteria: diagnosed with mechanical low back pain, body mass index (bmi) was between 30.00-39.99, 1.-2. forty-six patients, aged 20-50 years, who were extremely obese and had pain radiating to the lower back and hips for at least 3 months, exclusion criteria: -

Keywords: mulligan concept range of motion low back pain obesity
long-term outcome of triple-vessel coronary artery disease underwent three different strategies (lotus)

Conditions: Coronary Artery Disease; Coronary Stenosis; Myocardial Ischemia

Summary: the study is to determine the long-term outcome of patients with coronary triple vessels disease (tvd) in the real world of china, by three different treatment strategies: percutaneous coronary intervention (pci), coronary artery bypass graft (cabg) or optimal medication therapy (omt).

about 10,000 participants will be enrolled into this retrospective study. study coordinators will include both men and women over the age of 18 who had angiographic proved triple-vessel disease in a 15 years long-term. detailed procedural data will be obtained by the study coordinator and local principal investigator. these data will be entered into the electronic data capture system. participants will have telephone follow-up interviews conducted by the centralized follow-up center at fuwai hospital.

Eligibility criteria:
inclusion criteria: 1. subject has coronary angiography confirmed triple-vessel disease. 2. subject is ≥ 18 years of age at the time of inclusion. 3. subject is willing to comply with all protocol-required follow-up evaluation (patient will be followed during 1 month after hospital to assess any complications and clinical status). exclusion criteria: 1. subject is participating in another investigational clinical trial that may cause non-compliance with the protocol or confound data interpretation. 2. female subjects with a positive quantitative or qualitative pregnancy test, in accordance with hospital policy. 3. subjects with no way contact by telephone for follow-up.

Keywords: coronary artery disease percutaneous coronary intervention coronary artery bypass graft medication therapy
a study of phst001 in advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: phst001-101 is a multicenter, open-label, phase 1 study of phst001 in patients with advanced solid tumors. the study design includes a dose escalation phase and a dose expansion phase, and will enroll patients with advanced relapsed and/or refractory solid tumors. the study's primary object is to evaluate the safety and tolerability of phst001 and determine the rp2d (recommended phase 2 dose) of phst001.


Eligibility criteria:
key inclusion criteria: * histologically or cytologically confirmed advanced solid tumor which has relapsed from or been refractory to all locally available standard therapies. * adequate hepatic function: * ast and alt ≤ 2.5 × times uln (≤ 5 × uln if liver metastases) * total bilirubin ≤ 1.5 × uln (\<3 ×uln for patients with elevations due to gilbert syndrome) * lipase and amylase ≤ 2×uln * adequate renal function: calculated creatinine clearance of ≥ 30 ml/min calculated per institutional standard * adequate bone marrow function without packed rbc transfusion within the prior 2 weeks. patients can be on a stable dose of erythropoietin (approximately ≥ 3 months). criteria must be met without platelet transfusion within 7 days of screening blood draw: * absolute neutrophil count (anc) ≥1,500/µl * platelet count ≥100,000/µl * hemoglobin ≥9.0 g/dl or ≥5.6 mmol/la key exclusion criteria: * history of a previous additional malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years. patients with basal cell carcinoma of the skin, stage i melanoma, melanoma in situ, squamous cell carcinoma of the skin, early-stage prostate cancer, or carcinoma in situ, excluding carcinoma in situ of the bladder, who have undergone potentially curative therapy are not excluded and can be enrolled regardless of disease-free period following completion of potentially curative therapy. patients with early-stage breast cancer who have undergone curative intent treatment and with no disease recurrence for 2 years after treatment are not excluded. * active known cns metastases and/or carcinomatous meningitis. patients with previously treated cns metastases may participate provided they are radiologically stable (ie, without evidence of progression for at least 2 weeks by repeat imaging \[note that the repeat imaging should be performed during study screening\]), clinically stable, and without requirement of steroid treatment for at least 14 days prior to the first dose of study treatment. * received prior systemic anticancer therapy including investigational agents within 21 days or, if shorter, within 5 half-lives prior to the first dose of study treatment. patients must have recovered from all aes due to previous therapies to grade ≤1 or baseline. patients with grade ≤2 neuropathy may be eligible. patients with endocrine-related aes grade ≤2 requiring treatment or hormone replacement may be eligible. * prior autologous or allogeneic hematopoietic stem cell transplant or solid organ transplant. * received previous treatment with another agent targeting cd24.
study of bhq880 in patients with high risk smoldering multiple myeloma

Conditions: Smoldering Multiple Myeloma

Summary: this study will assess the antimyeloma effects of bhq880a in patients with smoldering multiple myeloma with high risk of progression to active multiple myeloma. bhq880 will be administered every 28 days in previously untreated patients. disease assessments will be performed monthly and effects on bone metabolism will be assessed by measurement of serum and urine bone biomarkers, changes in bmd , and qct with fea. additionally, the pk profile of bhq880 as a single agent and following multiple doses will be obtained.


Eligibility criteria:
inclusion criteria: 1. confirmed diagnosis of smm with high-risk for progression to multiple myeloma 1. bmpc ≥ 10% and serum m-protein level ≥ 3 g/dl, or 2. bmpc ≥ 10%, serum m-protein level \ 8.0 2. no previous or current anti-myeloma therapies 3. patients ≥ 18 years of age 4. eastern cooperative oncology group (ecog) performance status of 0 to 1 exclusion criteria: 1. previous treatment with iv bisphosphonates (i.e., pamidronate or zoledronic acid 2. another primary malignant disease that requires systemic treatment 3. concomitant paget's disease of bone, uncorrected hyperparathyroidism, or uncontrolled thyroid disease 4. clinically significant uncontrolled heart disease (e.g., unstable angina, congestive heart failure, uncontrolled hypertension, ventricular or atrial arrhythmias) 5. treatment with an investigational product within 28 days before the first dose of study treatment 6. pregnant or nursing (lactating) women 7. women of child-bearing potential, unless they are using two birth control methods. the two methods can be a double barrier method or a barrier method plus a hormonal method. other protocol-defined inclusion/exclusion criteria may apply

Keywords: high risk smoldering multiple myeloma, bhq880, mm
a prospective, non-interventional study of the use of dolutegravir as part of combination antiretroviral therapy in routine daily practice in germany

Conditions: Infection, Human Immunodeficiency Virus

Summary: dol-art is a multi-center, prospective, non-interventional study of the use of doluetegravir as part of an antiretroviral combination therapy in routine daily practice in germany. the primary study objective is a descriptive characterization of the frequency of therapeutic monitoring measures in hiv-infected patients under dolutegravir-containing art in routine daily practice in germany. the study is designed to enroll approximately 400 patients. there are no protocol-mandated visits or procedures associated with the study. each patient is expected to participate for a maximum of 3 years or until premature discontinuation (i.e., discontinuation of dolutegravir, due to death, withdrawal of consent, lost to follow-up).


Eligibility criteria:
inclusion criteria: * documented hiv infection * age ≥ 18 years * decision for the first initiation of dolutegravir as part of an art by the attending physician irrespective of inclusion in this observational study * prior to the start of this study, the patient must have been receiving a dolutegravir-containing art for at least 4 weeks exclusion criteria: * discontinuation of dolutegravir as part of an art prior to the start of the study documentation * participation in a clinical trial during this study * participation in a clinical trial or compassionate use program with dolutegravir being or having been part of the investigational medication
non-invasive hemoglobin monitoring in patients with hemorrhage

Conditions: Hemorrhage

Summary: this study will evaluate the accuracy of two rapid methods of measuring hemoglobin in patients with suspected hemorrhage. these methods will be compared with standard laboratory measurements.

anemia and bleeding are major causes of morbidity and mortality in both surgical and nonsurgical patients. the current standard of care for monitoring patients at risk for bleeding is serial measurement of hemoglobin levels. at present, the photometric cyanmethemoglobin method is the most widely used technique for monitoring hemoglobin in the lab, and is currently the gold standard. however, this method has potential for delay before final results are obtained. immediate hemoglobin measurements are available with portable point-of-care devices such as the istat, which can produce a measurement of hemoglobin concentration in less than 1 minute. unfortunately, the accuracy of this device has been reported to vary with hemoglobin level, and as such may not be as accurate in detecting blood loss when compared with the gold standard of laboratory analysis. recently, a noninvasive, spectrophotometry-based monitoring technology has been developed. this novel technology measures the differential optical density of wavelengths of light passed through the finger in a method similar to conventional pulse oximetry. while some studies have reported that this device appears to be accurate in patients undergoing elective surgical procedures, more recent work suggests that this accuracy degrades with increased blood loss, lower oximeter signal quality and lower absolute hgb values. we will evaluate the accuracy of point-of-care and non-invasive sphb measurements and utility of continuous hemoglobin monitoring in an intensive care unit setting. if these methods of rapid hemoglobin measurement can be validated in patients at risk for ongoing hemorrhage, use of this technology may result in earlier detection of ongoing hemorrhage, expedite appropriate treatment, and improve patient outcomes.

Eligibility criteria:
inclusion criteria: * admitted to surgical intensive care unit (sicu), and * at risk of ongoing bleeding, and * requires serial cbc measurements exclusion criteria: * \< 18 years of age, or * a prisoner, or * unable to have pulse oximetry readings (due to injuries, burns, amputations, or related problems)

Keywords: hemorrhage hemoglobin non-invasive monitoring medical device accuracy
effects of a physical exercise intervention during neoadjuvant chemotherapy in women with breast cancer

Conditions: Physical Exercise

Summary: to assess in women with triple-negative breast cancer receiving neo-adjuvant chemotherapy the effects of an intense physical exercise program (intervention group) on physical capacity, compared with a control group not meeting the minimum exercise recommendations of the world health organization (who).

justification and aims breast cancer is the fourth most common type of cancer worldwide and the first among women in spain. it is also the type of cancer with the highest mortality. several studies have assessed the effects of exercise performed in the neo-adjuvant period, but there is heterogeneity among them. principal aim: to assess in women with triple-negative breast cancer receiving neo-adjuvant chemotherapy the effects of an intense physical exercise program (intervention group) on physical capacity, compared with a control group not meeting the minimum exercise recommendations of the world health organization (who). secondary aims: to compare the following outcomes in both groups: body composition, and quality of life and depression/anxiety.

Eligibility criteria:
inclusion criteria: * diagnosed with breast carcinoma in the 'hospital universitario quirónsalud de pozuelo' (madrid, spain) and following neoadjuvant therapy in the aforementioned center. * must have triple negative breast cancer (i.e., negative for estrogen receptors, progesterone receptors, and excess her2 protein) of size \> or equal to 15 mm exclusion criteria: * not meeting all of the above.

Keywords: exercise high interval training resistance exercise
a language intervention study of preterm infants

Conditions: Language Development; Language Delay; Mother-Infant Interaction; Maternal Behavior

Summary: this is a randomized controlled trial to study a reading intervention in the nicu among preterm infants using lena (language environment analysis) recordings, linguistic feedback, and a language curriculum to improve the neonatal inpatient language environment and language outcomes for preterm infants.

this project aims to examine how an educational reading intervention in the nicu can impact preterm infant language development and examine the impact of reading on mother-infant autonomic systems. investigators plan to determine the effects of parent reading in addition to standard caretaking and holding on preterm infants, between 23 to 31 weeks gestation hospitalized in the women \& infants nicu, on adult word count, infant vocalizations, conversational turns through audio recording obtained over 3 separate days when the infant is corrected to 32, 34 and 36 weeks. investigators aim to determine the effect of parent reading on maternal and infant heart rate variability before, during, and after the shared reading intervention through video and a single channel electrocardiographic recording over the same 3 separate days as the lena recording. additionally, investigators aim to determine the effect of parent reading on maternal stress and perceived well-being in the nicu through a validated questionnaire and to determine parent satisfaction of a nicu reading intervention through a parent questionnaire completed prior to infant discharge and at the 12 month follow up visit. secondary outcomes include determining the effect of parent reading on infant dna methylation of the several genes through two saliva samples collected from the infant prior to study and post study enrollment and examine its relationship with infant stress and self-regulation based on a neurobehavioral exam performed at 36 weeks corrected age. final outcomes include examination of the long-term effect of inpatient shared reading education on infant receptive and expressive language development at 12 and 24 months. investigators hope this research will contribute to the growing research supporting early language development in preterm infants and its impact on maternal-infant well-being.

Eligibility criteria:
inclusion criteria: * 21-31 week infants, medically stable infants, english speaking mothers over 18 years old exclusion criteria: * intubated or medically unstable, major congenital anomalies, non english speaking

Keywords: language intervention preterm reading heart rate variability mother-infant interaction nicu network neurobehavioral scale lena
transport of satiety factors into the csf

Conditions: Obesity

Summary: the blood-brain barrier regulates the passage of peripheral built appetite-suppressing hormones from the blood to the brain and informs the brain about the nutritional- and energy status. the aim of this study is to investigate in which extent the hormones are able to overcome the blood-brain barrier and how long it takes after food intake. relating thereto indications to the effect of peripheral hormones in the central nervous system and the role of these hormones in the development of overweight are provided. in this study 30 patients (10 per intervention group) will be recruited. the patients are hospitalized in the local neurosurgery and they have a csf-drainage due to their neurological primary disease or due to neurosurgical interventions. the patients are examined in each case on the same day. simultaneous samplings of blood and csf are taken from 10 patients after an oral glucose tolerance test. these interventions are carried out to investigate in which extent the appetite-suppressing hormones (e.g. leptin, insulin, glp 1 and glucagon) reach the liquor and so the central nervous system. in order to understand the temporal sequence, simultaneous samplings of blood and csf are taken from 10 other patients at certain points throughout the day. in a further group of 10 patients will be investigated how the central effective insulin modulates the transport of the other appetite-suppressing hormones. therefore samplings of blood and csf are investigated before and after intranasal insulin administration.


Eligibility criteria:
inclusion criteria: * patients with cerebrospinal fluid drainage exclusion criteria: * women during pregnancy and lactation * participation in other interventional clinical trials * severe infection within the last 4 months * intake of central effective substances which may interact with the transport processes to be investigated * hypersensitivity to any of the substances used * diabetes mellitus * patients with csf results indicative of infectious diseases within the central nervous system * subjects with hemoglobin hb \<10 g / dl * patients with a neurosurgical disorder suspected of having a blood-brain barrier disorder
extension study of participants from spg302-als-001

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Summary: this study will evaluate the long-term safety and efficacy of participants enrolled in spg302-als-101 with amyotrophic lateral sclerosis (als)

this is an open-label extension study of spg302-als-001 to investigate the long-term safety, tolerability, and efficacy of spg302 administered orally in participants with amyotrophic lateral sclerosis (als). this study will allow participants in the parent study to continue dosing. enrolled participants will continue at the dose they received at the end of the first trial, and will self-administer spg302 orally every day for up to 52 weeks. participants will have an in-person clinic visit every 3 months (± 3 days) and a monthly phone visit. an end of treatment visit will occur within 7 days of the last dose of spg302. a final visit to collect safety data will be conducted up to 1 month (± 3 days) post last dose.

Eligibility criteria:
inclusion criteria: • must have participated in all study activities of spg302-als-001, the parent study exclusion criteria: * unable to reliably and regularly swallow whole oral medications on a daily basis. * medical conditions that investigator or sponsor determine would interfere with participation in clinical trial

Keywords: amyotrophic lateral sclerosis regenerative synapse